Evaluation of Safety and Efficacy of Using EndoClear-Endoscopic Lens Cleaning Device

NCT ID: NCT01197222

Last Updated: 2019-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-03-31

Brief Summary

Virtual Ports, Ltd., has developed a lens cleaning device, EndoClear, which is attached to the internal abdominal wall at the beginning of a surgical case and remains in position until completion of the surgery, enabling the surgeon to clean the camera lens without removing it from the abdominal cavity. The purpose of this study is to evaluate the efficacy and safety of using the EndoClear device as a laparoscopic lens cleaning device.

Detailed Description

The ability to perform laparoscopic surgery safely and effectively depends on the uninterrupted progression of the operation. Any interruptions to the normal workflow of the procedure threatens to cause distraction which in the least can lengthen the operative time leading to increased hospital operating costs and exposing the patient to unnecessary excess anesthesia and associated risks. At worst, interruptions can cause errors in judgment and/or technique resulting in injury to the patient.

Interruptions in the operating room can take many forms, from conversations to equipment malfunction. The goal of this study is to focus on one particular type of interruption unique to laparoscopic surgery - lens cleaning. It is quite common during the course of the procedure for the laparoscopic scope lens to become obscured by bodily fluids or steam from cautery devices. This necessitates having to remove the camera from the patient, cleaning it outside of the body, applying de-fog solution, reinserting it into the body, and having to reacquire the original camera position and image. This can be quite dangerous particularly in the middle of operative step, such as when there is ongoing bleeding, or when there are sharp or hot instruments within the body. Pilot data from own group demonstrates that the camera may have to be cleaned up to 20 times during a case adding upwards of 10-15 minutes to an operation.

Conditions

Laparoscopic Abdominal Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

EndoClear used

The EndoClear device is used during a laparoscopic abdominal surgery.

Group Type: ACTIVE_COMPARATOR

EndoClear Lens Cleaning Device

Intervention Type: DEVICE

EndoClear Lens Cleaning Device is used during a laparoscopic abdominal surgery.

Control

EndoClear Lens Cleaning Device not used during a laparoscopic abdominal surgery.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

EndoClear Lens Cleaning Device

EndoClear Lens Cleaning Device is used during a laparoscopic abdominal surgery.

Intervention Type: DEVICE

Other Intervention Names

Virtual Ports, Ltd

Eligibility Criteria

Inclusion Criteria

1. >18 years of age

2. Patients undergoing laparoscopic abdominal surgery

Exclusion Criteria

1. Patients with known coagulopathy or bleeding tendencies

2. Intra-abdominal abscesses

3. Pregnancy

4. Non-elective laparoscopic surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Oregon Clinic

OTHER

Sponsor Role: lead

Responsible Party

Lee Swanstrom

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lee L Swanstrom, MD

Role: PRINCIPAL_INVESTIGATOR

The Oregon Clinic

Locations

Legacy Good Samaritan

Portland, Oregon, United States

Countries

United States

Other Identifiers

940

Identifier Type: -

Identifier Source: org_study_id